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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM10CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX5MM10CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51005010L
Device Problems Indicator; Structural Problem; Catheter
Event Date 07/28/2017
Event Type  Malfunction  
Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt. A device history record (dhr) review of revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.

 
Event Description

As reported, the distance between the marker and the tapered part of the saber rx ((b)(4)) percutaneous transluminal angioplasty (pta) balloon catheter had different lengths at the distal and proximal ends. The difference of the length was more than double. There was no reported patient injury. The product was stored and handled according to the instructions for use (ifu). There was no damage noted to the packaging of the device. There was no difficulty in removing the products from the package. It was unknown how the procedure completed. The procedure finished successfully. The device will be returned for analysis. The patient¿s information was unknown. The target lesion was unknown. The patient¿s vessel level of tortuousness and calcification was unknown. The rate of stenosis was unknown.

 
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Brand NameSABER RX5MM10CM155
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel
co. tipperary
EI 
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel
co. tipperary
EI 
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes , FL 33014
MDR Report Key6809830
Report Number9616099-2017-01343
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/25/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2019
Device MODEL Number51005010L
Device Catalogue Number51005010L
Device LOT Number17565912
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/11/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/20/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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